A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma

Asthma Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376045
• Other study ID #: 20220093
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 10, 2024
• Est. completion date: October 2, 2026

Study information

• Verified date: April 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 428
• Est. completion date: October 2, 2026
• Est. primary completion date: August 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants must be between the ages of 18 and 75.
• Asthma diagnosed by a physician for = 12 months prior to the screening visit.
• Existing therapy with medium to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller (eg, LABA, leukotriene receptor antagonist [LTRA], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.
• Documented history of = 1 asthma exacerbation in the past year, with at least 1 exacerbation during treatment with medium to high doses of ICS (> 250 µg fluticasone propionate or equivalent ICS).
• Morning pre-BD FEV1 = 40% and = 80% of predicted normal at the screening visit and day 1 pre-randomization visits.
• ACQ-6 score = 1.5 at the day 1 pre randomization visit.

Exclusion Criteria:

• Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
• Any clinically important pulmonary disease other than asthma.
• Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of > 10 pack-years.
• Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
• Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
• Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
• Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
• History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
• Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
• Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
• Active and non-virally suppressed hepatitis B infection at initial screening,
• Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Rocatinlimab
Rocatinlimab will be administered by SC injection.
• Placebo
Placebo will be administered by SC injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period		Up to approximately two years
Secondary	Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)		Up to approximately two years
Secondary	Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period		Up to approximately two years
Secondary	Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48		Up to approximately two years
Secondary	Change From Baseline in Pre-BD FEV1		Up to approximately two years
Secondary	Change From Baseline in Asthma Symptom Diary (ASD) Score		Up to approximately two years
Secondary	Number of Participant Achieving ACQ-6 Response at Week 48		Up to approximately two years
Secondary	Change From Baseline in ACQ-6		Up to approximately two years
Secondary	Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score		Up to approximately two years
Secondary	Number of Participants Achieving AQLQ (S) Response at Week 48		Up to approximately two years
Secondary	Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period		Up to approximately two years
Secondary	Time to First Asthma Exacerbation Event		Up to approximately two years
Secondary	Time to First CompEx Event		Up to approximately two years
Secondary	Number of Participants with a CompEx Event During the Double Blinded Treatment Period		Up to approximately two years
Secondary	Annualized Rate of CompEx Events		Up to approximately two years
Secondary	Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels		Up to approximately two years
Secondary	Serum Rocatinlimab Concentrations		Up to approximately two years
Secondary	Trough Concentration (Ctrough) of Rocatinlimab		Up to approximately two years
Secondary	Number of Participants with Treatment-emergent Adverse Events		Up to approximately two years
Secondary	Number of Participants with Serious Adverse Events		Up to approximately two years
Secondary	Number of Participants with Anti-rocatinlimab Antibody Formation		Up to approximately two years

External Links

•   AmgenTrials clinical trials website